Effect of Patient Education in Rheumatic Diseases

• ClinicalTrials.gov Identifier: NCT00623922
• Recruitment Status: Completed
• First Posted: February 26, 2008
• Last Update Posted: April 8, 2015
• Sponsor: Norwegian University of Science and Technology
• Collaborator: The Research Council of Norway
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Tracking Information

• First Submitted Date: February 12, 2008
• First Posted Date: February 26, 2008
• Last Update Posted Date: April 8, 2015
• Study Start Date: February 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2008)

• Self efficacy [ Time Frame: Baseline, 4 and 12 months ]
• Well being (Arizona Integrative Outcomes Scale) [ Time Frame: Baseline, 4 and 12 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2008)

• Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role) [ Time Frame: Baseline, 4 and 12 months ]
• The Hospital Anxiety and Depression Scale [ Time Frame: Baseline, 4 and 12 months ]
• Educational Needs Assessment Tools [ Time Frame: Baseline, 4 and 12 months ]
• Modified Health Assessment Questionnaire [ Time Frame: Baseline, 4 and 12 months ]
• DAS 28 score (Disease activity score) [ Time Frame: Baseline, 4 and 12 months ]
• Patient Activation Measurement (PAM) [ Time Frame: Baseline, 4 and 12 months ]
• Cost- benefit [ Time Frame: Baseline, 4 and 12 months ]
• Physical activity [ Time Frame: Baseline, 4 and 12 months ]
• Use of medications [ Time Frame: Baseline, 4 and 12 months ]
• fatigue (VAS scale) [ Time Frame: Baseline, 4 and 12 months ]
• Pain (VAS scale) [ Time Frame: Baseline, 4 and 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Patient Education in Rheumatic Diseases
• Official Title: The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.

Brief Summary

The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that

- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.

• Detailed Description: There has been a rather long tradition of PE for patients with arthritis. A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. This indicates that the present forms of interventions fails to show a long term effect. One possible reason for the lack of long term effect might be that these interventions are given to groups only. Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Polyarthritis

Intervention

Behavioral: Patient education with individual nurse consultations

3 group meetings followed by 1-2 individual nurse consultations.

Study Arms

• Experimental: 1
  Patient education
  Intervention: Behavioral: Patient education with individual nurse consultations
• No Intervention: 2
  Usual care

Publications *

• Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.
• Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.
• Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
• Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2012): 141
• Original Estimated Enrollment (submitted: February 24, 2008): 142
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Polyarthritis
• 18-80 years
• native Norwegian speaking
• able to understand and participate in the PE program

Exclusion Criteria:

• Participated in a patient educational program the latest 12 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT00623922
• Other Study ID Numbers: 4.2007.2472; NSD 17975
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Norwegian University of Science and Technology
• Original Responsible Party: Kjersti Grønning, Norwegian University of Science and Technology
• Current Study Sponsor: Norwegian University of Science and Technology
• Original Study Sponsor: Same as current
• Collaborators: The Research Council of Norway

Investigators

• Principal Investigator: Aslak Steinsbekk; Norwegian University of Science and Technology
• Principal Investigator: Kjersti Grønning; Norwegian University of Science and Technology

• PRS Account: Norwegian University of Science and Technology
• Verification Date: April 2015